C
Cellardoor
I am working at a small medtech company that develops a self-help device for diabetics. At the moment I am working with establishing the SOP for risk managment, in according with ISO 14971:2012. However, the risk/benefit analysis gives me some trouble. We should prove that the benefit outweighs the risks for all risks. Our consultant, who is a risk management expert, said that we need to write a motivation for every risk/benefit analysis. Since this work would be tedious if we take each risk separately, our risk management expert suggested that we should group the risks together according to certain parameters and then determine the benefit/risk for each group.
Acccording to what principles/criteria is it better to group one group risks together?
Has anyone in here been in a similar situation and/or has any suggestion about how to solve this?
Acccording to what principles/criteria is it better to group one group risks together?
Has anyone in here been in a similar situation and/or has any suggestion about how to solve this?